Care Ets
510(k) K023036
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK023036 | Date19 Jun 2003 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IPF
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5850
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The Care Ets is physical therapy equipment designed for transcutaneous electrical nerve stimulation and muscle stimulation. It functions as a therapeutic device to provide electrical stimulation for physical medicine applications.
This device is supplied by Care Rehab and Orthopaedic and has received FDA 510K clearance. It is identified by K-number K023036.
Other devices from Care Rehab and Orthopaedic
Questions
AI-generated answers, 27 Sep 2026
What is the primary function of the Care ETS?
The Care ETS is a therapeutic device engineered for physical medicine applications. It provides transcutaneous electrical nerve stimulation and muscle stimulation to assist in physical therapy treatments.
What is the regulatory status of this device?
The Care ETS has received FDA 510K clearance under K-number K023036. This indicates that the device has been reviewed and determined to be substantially equivalent to other legally marketed devices.
Who is the manufacturer of the Care ETS?
The device is manufactured by Care Rehab and Orthopaedic, located in Mclean, Virginia. They are the primary applicant responsible for the device submission and clearance.